Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

Asthma Clinical Trial

Official title:

Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01066416
• Other study ID #: 0001
• Status: Terminated
• Phase: N/A
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2019
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is unknown whether surgical treatment of chronic sinusitis improves asthma control in patients with poorly controlled asthma. This is a randomized trial of surgical plus medical sinus therapy versus medical therapy alone.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion criteria: General

1. 18 years of age or older

2. Women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status

3. Informed consent and ability to comply with study procedures

4. Patients must meet inclusion criteria for both asthma and sinus disease.

Inclusion criteria: Asthma

In order to qualify for the 6 week run-in, patients must have poorly controlled asthma as defined by the following criteria:

1. Diagnosis of asthma confirmed either by demonstrating a positive methacholine challenge test (defined as a decrease in FEV1 by at least 20%, following administration of 8mg or less of inhaled methacholine) or a positive bronchodilator response (defined as a change from base line of >12% and at least 200ml in either FEV1 or FVC, following administration of a short-acting, inhaled bronchodilator).

2. Either:

• Asthma Control Questionnaire score > 1.5 or

• Use of inhaled rescue ß-agonist >/= 16 puffs per week (excluding use as a pre-medication for exercise; 1 nebulizer treatment = 2 puffs of inhaler) at any time during the past month or

• >1 hospitalization or unscheduled MD visit in the past 6 months for asthma symptoms or

• >1 course of oral steroid use in past 6 months or

• > 2 weeks of systemic steroids in last 6 months.

Exclusion Criteria:

1. Current smokers or those with at least a 10 pack-year smoking history

2. Presence of any concurrent diseases that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk

Related Conditions & MeSH terms

• Asthma
• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Procedure:
• Endoscopic Sinus Surgery

Other:
• medical therapy
Subjects will undergo surgery 6 months after randomization

Locations

Country	Name	City	State
United States	Evanston Hospital	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Score